A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | Completed
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
ANDANTE
Trial Source

Health Conditions
  • Crohn's Disease
Completed
Recruitment Status
NCT01287897
Primary Trial ID Number
Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Primary Outcome Measures
  • The Crohn's Disease Activity Index (CDAI) 70 response rate at Week 8 or Week 12; Baseline, Weeks 2, 4, 6, 8, 10 and 12
Secondary Outcome Measures
  • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses; Weeks 2 through 12; Mean change from baseline for CDAI score; Weeks 2 through 12; Percent of subjects that develop anti drug antibodies (ADAs) and neutralizing antibodies (NAbs), if observed; baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40; Serum concentrations of PF 04236921; Baseline, Weeks 2, 4, 6, 8, 10 and Week 12 and monthly through Week 40
Research Question
  • This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Australia; Belgium; Brazil; Canada; Czech Republic; Denmark; France; Germany; Greece; Hungary; Ireland; Israel; Italy; New Zealand; Romania; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Subjects must have failed or are intolerant to anti TNFs
  • - hsCRP greater or equal to 5.0 mg/L
  • - Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
  • within 8 weeks of study entry (screening) and able to retrospectively complete the
  • SES-CD or colonoscopy performed during screening
  • Exclusion Criteria:
  • - Pregnant or breastfeeding women
  • - Crohn's Disease with active fistulae or abscess
  • - History of diverticulitis or symptomatic diverticulosis
  • - Abnormality in hematology or chemistry profiles at screening
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Subjects must have failed or are intolerant to anti TNFs
  • - hsCRP greater or equal to 5.0 mg/L
  • - Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
  • within 8 weeks of study entry (screening) and able to retrospectively complete the
  • SES-CD or colonoscopy performed during screening
  • Exclusion Criteria:
  • - Pregnant or breastfeeding women
  • - Crohn's Disease with active fistulae or abscess
  • - History of diverticulitis or symptomatic diverticulosis
  • - Abnormality in hematology or chemistry profiles at screening
Interventions
Drug; PF-04236921 SC injection; Placebo delivered SC, 2 doses separated by 4 weeks; [Placebo- SC injection]; Drug; PF-04236921 SC injection; Drug dose level 1 delivered SC, 2 doses separated by 4 weeks; [Drug Dose level 1 - SC injection]; Drug; PF-04236921 SC injection; Drug dose level 2 delivered SC, 2 doses separated by 4 weeks; [Drug Dose level 2 - SC injection]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
ANDANTE
Scientific Title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
Secondary Trial Identifying Number
2010-023034-23; ANDANTE
Website
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0151003&StudyName=A%20Study%20To%20Assess%20The%20Efficacy%20And%20Safety%20Of%20PF-04236921%20In%20Subjects%20With%20Crohn%27s%20Disease%20Who%20Failed%20Anti-TNF%20Therapy
Study Funded By
Pfizer
Funder Type
Sorry, this information is not available
Study Sponsored By
Pfizer
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

31 Jan 2011

Last Updated

20 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015